A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Stanford University
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01364259
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
  Purpose

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.


Condition Intervention Phase
Trigeminal Neuralgia
Drug: Amifostine
Procedure: CyberKnife stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Facial numbness following radiosurgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percent of patients with facial numbness following radiosurgery will be determined.


Secondary Outcome Measures:
  • Pain relief following radiosurgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain score following radiosurgery will be measured. Latency to pain relief will be assessed.


Estimated Enrollment: 208
Study Start Date: September 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo and SRS
Procedure: CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery
Other Name: CyberKnife stereotactic radiosurgery
Experimental: Amifostine
Amifostine and CyberKnife stereotactic radiosurgery
Drug: Amifostine
Amifostine and CyberKnife stereotactic radiosurgery
Other Name: CyberKnife stereotactic radiosurgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

  • Intolerant of or refractory to medical management; AND
  • Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

  • Patients who present with pre-existing BNI grade III or IV facial numbness.
  • Patients who have previously been treated with MVD.
  • Patients who have previously had an ablative treatment, including prior SRS.
  • Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364259

Contacts
Contact: Lisa Jacobs (650) 723-8843 ljacobs@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lisa Jacobs    650-723-8843    ljacobs@stanford.edu   
Principal Investigator: Scott Soltys         
Principal Investigator: Clara Choi         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Clara Choi Stanford University
Principal Investigator: Scott Soltys Stanford University
  More Information

No publications provided

Responsible Party: Clara Choi, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01364259     History of Changes
Other Study ID Numbers: SU-05252011-7806
Study First Received: May 26, 2011
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
tic douloureux

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014